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ECJ rules no new SPC for drug already authorised for different use

Date: 28 October 2020


In a decision on July 9, 2020, the European Court of Justice (ECJ) ruled that supplementary drug protection certificates (SPC) for drugs can no longer be issued in future if the drug is the first to use an active ingredient or a combination of active ingredients for a new specific therapeutic use, but the active ingredient or the active ingredient composition is already the subject of an approved medicinal product for another therapeutic use (ECJ, judgment of 9 July 2020, C-673/18 “Santen”).


The judgement detailed the following:


"Article 3(d) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that a marketing authorisation cannot be considered to be the first marketing authorisation, for the purpose of that provision, where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of a marketing authorisation for a different therapeutic application."


For the complete decision, see: Case C‑673/18


Ophthalmology company Santen is the owner of a French patent (FR 05 795 9306), which protects an ophthalmic emulsion with the active ingredient cyclosporine (an immunosuppressant) called "Ikervis". Santen had received marketing authorization from the European Medicines Agency (EMA) on March 19, 2015 for the treatment of severe corneal inflammation in adults with dry eyes after certain failed previous treatments. On June 3, 2015, Santen applied for an SPC for a product called "Cyclosporin for use in the treatment of corneal inflammation" at the competent office in France, the INPI. This was rejected because on December 23, 1983 a marketing authorization for a product called "Sandimmun" containing cyclosporine as an active ingredient had already been granted.


At the end of the legal proceedings, the ECJ issued the above judgment, which basically confirmed the rejection by the INPI.


This constitutes a clear deviation from and rejection of an interpretation of an earlier decision (ECJ, judgment of 07/19/2012 “Neurim Pharmaceuticals”, C-130/11), which stated that an earlier veterinary marketing authorization of an active substance would allow the granting of an SPC for another therapeutic application of the same active ingredient.


As a result, SPCs for further therapeutic uses in Europe were granted in a number of European countries. However this is no longer possible. The “Santen” judgment means a complete departure from “Neurim”.


In addition to new formulations (ECJ, judgment of March 21, 2019, C-433/17 “Abraxis Bioscience”) of an active ingredient with new carrier materials, new therapeutic uses are no longer accessible to protection by an SPC. This judgement significantly reduces the number of drugs available to an SPC. In principle, this means a reduced incentive to develop new formulations and therapeutic uses.


Please see more on the history of this case here: More than one SPC for the Same Medical Product